RESUMEN
INTRODUCTION: Uncomplicated surgical approaches that minimize anastomotic complications while improving revisional metabolic/bariatric surgical (MBS) outcomes are needed. METHODS: This prospective single-center study assessed the feasibility, safety, and efficacy of the novel linear magnetic anastomosis system (LMAS [3 cm]) in performing a side-to-side duodeno-ileostomy (MagDI) bipartition to revise clinically suboptimal primary sleeve gastrectomy (SG). Patients with severe obesity with/without type 2 diabetes (T2D) with suboptimal weight loss, regain, and/or T2D recurrence post SG underwent revisional MagDI. A distal and proximal magnet were delivered endoscopically to the ileum and duodenum and aligned via laparoscopic assistance. Gradual magnet fusion formed a DI bipartition. PRIMARY ENDPOINTS: technical feasibility, safety (Clavien-Dindo [CD] severe adverse event classification) at 1 year. Secondary endpoints: MBS weight and T2D reduction. RESULTS: July 29, 2022-March 28, 2023, 24 patients (95.8% female, mean age 44.9 ± 1.5 years, and body mass index [BMI] 39.4 ± 1.3 kg/m2) underwent MagDI. Feasibility was attained via correct magnet placement (mean operative time 63.5 ± 3.3 min), patent anastomoses created, and magnet passage per anus in 100.0% of patients. There were 4 CD-III mild or moderate severe AEs, 0.0% associated with the LMAS or MagDI: 0.0% anastomotic leakage, obstruction, bleeding, infection, reintervention, or death. Mean BMI reduction was 2.1 kg/m2 (p < 0.05); total weight loss 5.3%, excess weight loss 16.4%; and the patient with T2D improved. CONCLUSION: The single-anastomosis MagDI procedure using the novel 3-cm LMAS to revise clinically suboptimal SG was technically straightforward, incurred no major complications, mitigated weight regain, and renewed clinically meaningful weight loss. GOV IDENTIFIER: NCT05322122.
